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The seminar provides an overview of the applicable laws that apply in this regulated environment. What requirements does a medical device manufacturer have to meet? Which responsibilities can be delegated to customers or suppliers and which cannot?
This seminar also discusses the liability risks for companies and employees. Also: what are the reporting requirements? How should the cooperation with doctors and clinics be structured? How are conformity assessment procedures to be carried out - which innovations have to be taken into account here, eg new classifications of medical devices?
topic overview
- Overview of the legal framework at German and European level
- Classification of medical devices, differentiation from medicinal products and other products, conformity assessment procedures
- Obligations and regulations to be observed for placing medical devices on the market, in particular proper labeling of medical devices
- Clinical evaluation and clinical testing
- instructions for use
- Obligations in the monitoring of medical devices, PMS and PMCF
- reporting requirements
- Competent authorities and their tasks, legal protection against authorities and notified bodies
- Criminal and civil liability risks of employees and managing directors
- Contract design and product liability risks at a glance
- Drafting of contracts for cooperation with doctors, clinics and sales agents
- Manufacturer liability and correct procedure in product liability cases
- Requirements for third-country manufacturers (including Switzerland, UK)
target group
Managing directors and board members, executives and employees of manufacturers, dealers and importers of medical devices and medical technology retailers.
previous knowledge
Not mandatory.
KONTAKT:
Online
